HIV Prevention
Conditions
Keywords
ACT, PrEP
Brief summary
Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP.
Detailed description
Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP. Specific Aim 1) Gather data from YBMSM (n = 20) and clinic staff (n = 10) through in-depth interviews to assess quantitative measures, intervention design, and experiences most relevant to PrEP engagement. Specific Aim 2) Develop ACTPrEP utilizing Aim 1 data, working iteratively with experts, and an intervention "run through" with a sample of participants. CLINICAL TRIAL IS AIM 3 ONLY Specific Aim 3) Evaluate ACTPrEP. Enroll 66 participants. Primary outcomes will be feasibility (measured by percentage eligible, consented, randomized, and retained) and acceptability (measured by the Client Satisfaction Questionnaire). Secondary outcomes will compare ACTPrEP vs. enhanced standard of care condition (ESOC) on behavior outcomes (uptake, adherence, and PrEP persistence) and possible mediators over the course of 24 weeks. Barriers and facilitators to implementing ACTPrEP will be assessed with post-RCT qualitative interviews using the i-PARIHS framework.
Interventions
BEHAVIORALACTPrEP
ACTPrEP will include a 60-minute initial session and a series of 30-minute follow-up sessions. Sessions will focus on the Thoughts, Emotions, Associations, Memories, and Sensations (TEAMS) relevant to PrEP uptake and adherence.
BEHAVIORALEnhanced Standard of Care
Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.
Sponsors
Rhode Island Hospital
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * Between 18-34 years old * Male sex assigned at birth * Identify as African American/Black * Not enrolled in another PrEP related study * Able to give consent * Not taken PrEP in past 3 months * Report having sex with a man in the past 3 months * PrEP-eligible according to CDC guidelines
Exclusion criteria
* Participating in another PrEP study * Unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACTPrEP Feasibility | 12 week visit | ACTPrEP feasibility is measured by percentage of participants retained in the study. |
| ACTPrEP Acceptability | 12 week visit | Acceptability is measured with the Client Satisfaction Questionnaire. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTrisha Arnold, PhD
Rhode Island Hospital
Outcome results
None listed